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Mick TP MANUAL Mar tweezer
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Document Sample
MICK® 200-TP Applicator Kit
Catalog # 8810
Instructions for Use
Date: _________________
Model # 8810
Serial #_______________
For future references, please note the applicator’s serial number
shown in the box above.
The applicator’s serial number is stamped into the Magazine Receptor of your
Mick 200-TP Applicator.
SERVICE YOUR MICK 200-TP APPLICATOR REGULARLY!
An ISO 13485 Certified Company
521 Homestead Avenue
Mount Vernon, New York 10550 USA
Tel: 914-667-3999 / Fax: 914-665-8834 / Toll-Free: 877-597-MRNI
E-mail: sales@micknuclear.com / Website: www.micknuclear.com
Form #: 405-05; Rev. F; 03/30/07
Table of Contents
General Information
MICK 200-TP APPLICATOR
TABLE OF CONTENTS.................................................................................................................... Page 1
GENERAL INFORMATION..…………………………………..........……................ Page 1
MICK 200-TP APPLICATOR KIT...................................................................................................... Page 2
CONTENTS.......................................................................................................... Page 2
MICK 200-TP APPLICATOR ............................................................................................................ Page 3
PARTS DESCRIPTION …………………………………..................................…... Page 3
MICK 200-TP APPLICATOR (Continued)....................................................................................... Page 4
SCHEMATIC ILLUSTRATION ……………...........................……......................... Page 4
IMPORTANT APPLICATOR DETAILS ………….....................................................……..........…… Page 5
NEEDLE RECEPTOR …………………………………………………........………... Page 5
MAGAZINE RECEPTOR ……………………………………………........……….…. Page 5
MICK MAGAZINE (I-125 / Pd-103)……………………………….................……………….........…… Page 6
TECHNICAL DESCRIPTION ………………………………………………….......… Page 6
INSTRUCTIONS FOR USE ………………………………………………….......….. Page 6
MANUAL SEED LOADING …………………………………………………........….. Page 6
MICK MAGAZINES — CONTINUED................................................................................................ Page 7
NEW DESIGN NOTICE........................................................................................ Page 7
RECOMMENDED SERVICE SCHEDULE........................................................... Page 7
MICK MAGAZINES........................................................................................................................... Page 8
VARIOUS TYPES ………………………………………………………................... Page 8
STERILIZATION PROCEDURES ………………………………………………..... Page 8
RADIATION SAFETY ……………………………………………………………...... Page 8
WASTE DISPOSAL ………………………………………………………………..... Page 8
STERILIZATION PROCEDURES ................................................................................................... Page 9
VALIDATED …………………........………………….……................................….. Page 9
CLEANING PROCEDURES............................................................................................................. Page 10
RECOMMENDED …………………………………….........…………..................... Page 10
MICK “RIPPLE-HUB” NEEDLE...................................................................................................... Page 11
NEEDLE SPECIFICATIONS ………………….……........……............................ Page 11
MICK “RIPPLE-HUB” NEEDLE (Continued)................................................................................. Page 12
DETAILED ILLUSTRATION ………………..........……………............................ Page 12
MORGENSTERN STABILIZATION NEEDLES ………….……………………........…..…………….. Page 13
PRECAUTIONS……………………………………………………………………………………………. Page 14
RADIATION SAFETY………………………………………………………………… Page 14
RADIATION PROTECTION…………………………………………………………. Page 14
IMPLANT SEQUENCE..................................................................................................................... Page 151& 16
RECOMMENDED …………………………………………….........………............. Page 15 & 16
USEFUL TIPS ………………………………………………………………………………..........……..... Page 17
PREPARATIONS ……………………………………………………………….......... Page 17
CAUTION............................................................................................................. Page 17
SEED ACCOUNTABILITY ……………………………………………………........... Page 17
POST SURGERY CHECKS ……………………………………………………........ Page 17
BALL-TIPPED PROTECTIVE SHEATH............................................................... Page 17
USEFUL TIPS (CONTINUED)…………………………………………………………………………….. Page 18
THINGS TO BE AWARE OF…………………………………………………………. Page 18
RETURN AUTHORIZATION / RETURNING “HOT” APPLICATORS / WARRANTY / DISCLAIMER Page 19
1
Mick® 200-TP Applicator Kit
Contents
Kit Consists of:
1. 1 EA CAT. # 8810-I MICK 200-TP APPLICATOR INSTRUMENT
2. 8 EA CAT. # 7609 SEED MAGAZINES - REUSABLE (I-125 or Pd-103)
* 3. 1 EA CAT. # MTP-17/18-20C “AUTHENTIC” MICK TP NEEDLES, DISPOSABLE
4. 1 EA CAT. # 7509 LOADING V-BLOCK
5. 1 EA CAT. # 7901 SEED STERILIZER & CARRIER
6. 1 EA CAT. # 8816 DIDDLER
7. 1 EA CAT. # 7613 REVERSE ACTION TWEEZER
8. 1 EA CAT. # 7702 LOOP WIRE
9. 1 EA CAT. # 7610 STAINLESS STEEL RULER (15CM)
10. 4 EA CAT. # 7609-E E-RINGS - (SPARES)
11. 1 EA CAT. # 7311-C ST. STEEL ALLENWRENCH
12. 1 EA CAT. # 8113-PIP PRACTICE PHANTOM + 100 DUMMY SEEDS
13. 1 EA CAT. # 0506 STERILIZATION / STORAGE CASSETTE
14. 1 EA INSTRUCTION MANUAL
*NOTE: 1 CARTON OF MICK “RIPPLE-HUB” TP NEEDLES ARE PROVIDED WITH THE KIT,
CHOICE OF 17 OR 18 GAUGE.
2
Mick 200-TP Applicator
Parts Description
Mick 200-TP Applicator - Cat: # 8810-I
14
9
12
7
5
2 13
1 11
10
3 8
4 6
Template Ring (1):
The Template Ring (1) which is connected to the Black Cone (10) by means of two parallel
rods, serves as a foot (reference point) when placed against the transperineal template. It is
Parts
important to keep the Template Ring moving freely on the Main Barrel. If motion is hampered,
turn slotted screw located on top of the Black Cone (10) 1/2 turn counter clock wise. If problem
Description
remains, return the Applicator to Mick Radio-Nuclear Instruments, Inc. for repair.
1. Template Ring
Needle Release Button (2): 2. Needle Release Button
The needle release button (2) is under spring tension to ensure capture of the inserted Mick 3. Mick TP Needle
“Ripple-Hub” Needle (3). When blocked by residual blood and tissue, the release button may
stick and needles may not hold. It is imperative to keep this part of the instrument clean and 4. Needle Receptor
free of blood. Use lubrication to ascertain free movement of the needle release button. 5. Magazine Receptor
Continuously rinse the Applicator in sterile water during surgery.
6. Serial Number
7. Seed Cartridge
Magazine Receptor (5):
8. Template Ring
Upon removal of the Seed Cartridge (7), the magazine receptor (5) must be kept clean and
free of blood. When blood appears in the magazine receptor, rinse the entire front portion Stabilizer
of the applicator in STERILE WATER to free up biological matter. 9. Finger Ring
10. Black Cone
Pushwire Rod Assembly (13): 11. Adjustment Screw
The pushwire rod assembly, (13) should be removed upon completion of an implant for
12. Main Barrel
cleaning. To do so, turn the knurled main barrel end-cap (13) counter clock-wise until the entire
assembly can be pulled out of the main barrel. Clean the inner part of the barrel together with 13. End Cap &
the pushwire rod assembly by means of ULTRASONIC CLEANERS. Remove after 15
Pushwire Rod
minutes and rinse with warm water. After steam sterilization, instruments tend to be dry and
sterile water will ensure for smooth motion. Carefully reinsert stylet / pushwire rod assembly Assembly
back into barrel and turn end-cap clock-wise until it is tight.
14. Pushwire Knob
♦ Stylet must be straight and move freely through the applicator and needle.
♦ Defective Applicators must not be used for surgery; return Applicator to Mick Radio-
Nuclear Instruments, Inc. for service or repair.
3
Mick 200-TP Applicator
Schematic Illustration, Major Components & Moving Parts
The Mick 200-TPV Applicator consists of 6 major components and 4 moving parts:
Major Components: Needle Receptor / Magazine Receptor / Main Barrel / Black Cone /
Template Ring / Pushwire Rod Assembly.
(Needles and Magazines are excluded)
Moving Parts: Black Cone / Pushwire Rod Assembly (Stylet) /
Template Ring Rod Assembly / Needle Release Button.
Please note: The Needle Receptor is not shown in detail in this diagram due to its intricacies.
Schematic Illustration
of Mick 200-TP
Applicator
Template Ring is connected to the
Black Cone. Both components move
simultaneously along the Main Barrel.
Main Barrel End Cap
Holds Pushwire Rod Assembly in
place, (See bottom page 3)
Pushwire Rod Assembly
Serves to manually insert seeds.
(Moves stylet through needle)
Pushwire Rod Assembly (All one unit - Do not disassemble)
Unscrew from Applicator for cleaning and sterilization
Stylet (must remain straight) Pushwire Rod Guide Pushwire Knob
Pushwire Rod Pushwire Rod End Cap
Items Not To Be Tampered With:
♦ Template Ring Rod Assembly must not be removed or disassembled.
♦ Needle Receptor must not be disassembled.
Items to be disassembled for cleaning:
♦ Pushwire Rod Assembly (The pushwire rod assembly consists of four parts; stylet, pushwire rod guide,
pushwire rod and pushwire knob.) If the stylet is bent or kinked, return instrument for repair.
For best cleaning results, unscrew the pushwire rod assembly from the applicator and clean
as recommended on page 10.
4
Important Applicator Details
Needle Receptor
Mick Magazine Receptor
Needle Receptor & Magazine Receptor Needle Receptor:
The needle receptor, sometimes referred to as the
“needle chuck”, is most likely to cause problems
Shielded / Disposable Magazine Receptor when unattended. Blood can accumulate inside
Magazine (Shielded) causing the needle grabbing mechanism to stick
which prevents the needle from properly seating
within the applicator. Consequently, seeds may
jam! Continuous rinsing in sterile water has proven
Needle Release to be very effective in keeping the Applicator and
Button its moving components in optimal operating condi-
tions.
Caution:
Ascertain that needles are “firmly” held captive
when inserted into the Applicator’s needle recep-
tor! Perform pull-test. Ascertain that the yellow or
blue sleeve of the needle completely disap-
pears within the needle receptor. If the colored
Needle Receptor needle sleeve is protruding and visible, a seed
jam is very likely to occur.
Mick Magazine Receptor The Magazine Receptor, shown to the left and be-
low, provides a well for the insertion of Mick Maga-
zine. The magazine’s design allows for insertion of
Mick Magazine Well magazines with capacities of up to a maximum of
20 seeds. The Magazine Receptor fully encircles
an inserted portion of the shielded Mick Magazine
thus providing excellent all-around radiation shield-
ing.
The magazine receptor accepts Mick magazines by
conveniently clicking them into the Magazine Well.
There is a lock-out to ensure the magazine can be
Applicator Serial inserted with “seeds facing to the right” only! (See
Number (Engraved) page 6.)
Please note: Drainage Slots (4)
The Magazine receptor must be kept free of blood at
all times. It is therefore highly recommended that
flushing and rinsing by means of sterile water under
pressure, is carried out continuously during the implant
procedure.
Ignoring the recommendation may result in the IN-
ABILIITY to seat the Mick Magazine correctly. If the
Mick Magazine is seated incorrectly, seeds may not be
ejected from the magazine thus causing the magazine
to jam.
Use Ultrasonic Cleaners for best cleaning results! Additionally, the bottom of the Magazine Receptor
(See page 10.) is provided with 4 drainage slots for ease of rinsing
and cleaning.
5
Mick Magazines
Technical Description / Instructions for Use / Manual Seed Loading
♦ Mick Magazines are designed for use with I-125 and Pd-103 seeds.
♦ All Mick Magazines are IDENTICAL in PRINCIPLE.
♦ Handling, precautions and seed loading procedures are identical for all magazines.
Shielded Disposable Mick Magazine Insertion of Magazine into the Mick Applicator
Always Insert Magazine Seeds
E-Ring Warning! Facing to the Right!
(Snap-Ring) Do Not Handle
Magazine by the MICK MAGAZINES ARE
Spring-Loaded DESIGNED TO SEAT INTO THE
Plunger MICK APPLICATOR BY SIMPLY
PUSHING IT INTO THE
MAGAZINE RECEPTOR WITH A
Threaded Round NOTICEABLE “CLICK”.
Magazine Head Magazine WARNING:
for storage in Head
Seed Sterilizer Brass –Coated MICK MAGAZINES ARE NOT DESIGNED TO SCREW INTO
(see below) (Color Silver) OR OUT OF THE APPLICATOR. THE OUTSIDE THREADS
ARE TO BE USED TO AFFIX MAGAZINES TO THE V-
BLOCK FOR SEED LOADING AND TO THE SEED STERI-
LIZER BLOCK FOR STERILIZATION. (See below.)
Fully loaded Mick
Cartridge. DO NOT LOAD MICK MAGAZINES ABOVE THE
Seed Cartridge Seeds are CAPACITY OF SEEDS SPECIFIED!
(PES) stacked parallel OVERLOADING WILL CAUSE SEEDS TO JAM!
(Color White) on top of each
other. ♦ Do not handle the magazine by the protruding
spring-loaded plunger.
♦ Do not over tighten the round magazine head.
Loaded Seed Magazines stored in Seed ♦ Do not let seeds drop into the slot of the seed
Sterilizer Block cartridge.
♦ Do not use force on seeds; handle seeds gently!
Radiation Protection: ♦ Initiate radiation surveys on all components upon
Readings taken at the handle completion of seed implants.
of the Seed Sterilizer Block ♦ Use appropriate radiation protection and precau-
(outside the housing) contain- tions when handling radioactive materials.
ing 150 each I-125 Seeds with
a total activity of 53.1mCi ♦ ASCERTAIN THAT ALL CARTRIDGES ARE
measured 0.02mR/h. “EMPTY” PRIOR TO DISPOSAL.
Manual Seed Loading • Place 10, 15 or 20 Seeds into the well of
the Seed Loading V-Block.
• Hold the Reverse Action Tweezer as
Magazine Storage (5) Seed Well Hold shown with the 3 marks on “top”! (Grooved
tweezer tweezer tip must be up).
with the 3 • Pick up a seed as close to the center as
marks possible.
(grooves) • Align the seed with the slot in the seed
facing cartridge.
upwards • Feed the seed down into the slot until it is
to grab a seated on the bottom of the cartridge or on
seed. top of the previous seed. Empty Cartridge /
• Release the seed and pull tweezer out Loaded Cartridge /
straight. Disassembled
• Pick up the next seed and continue loading Cartridge
as above.
CAUTION: DO NOT DROP SEEDS INTO CARTRIDGES AND
ALWAYS USE PROPER RADIATION PROTECTION.
6
Mick Magazines Continued
New Design Notice
Recommended Service Schedule
Plunger Up / Plunger Down
Be aware of remaining seed in cartridge!
Recently the design of the Dis-
posable Mick cartridge for the
Mick Applicator was changed for
smoother operation and produc-
tion safety.
With the new design it is now
possible, that the last seed is
not directly visible under certain
viewing angles, although there
is still one in the cartridge.
When you look under 90° to the
Seed visible when Seed invisible when cartridge axis you can’t see the
looking down into looking up into the
last seed anymore, only the
the cartridge. cartridge.
lifted plunger on top indicates
Left: 1 seed left in cartridge; there is still a seed inside.
plunger is sticking up.
Right: No seed left in cartridge;
plunger down.
Check for remaining seeds by inspecting the plunger first, then look for a last seed
under an appropriate viewing angle, if unsure use a radiation detector.
Before disposing empty cartridges always check with a contamination monitor,
that they are free from any contamination.
CONDUCT RADIATION SURVEY!
RECOMMENDED SERVICE SCHEDULE FOR
MICK APPLICATORS AND MICK REUSABLE MAGAZINES
The Mick 200 –TP Applicator, Mick 200-TPV Applicator and Mick Reusable Magazines are
designed for reuse and are to be cleaned and sterilized prior to each use.
These products contain no user serviceable components.
Any and all repairs must be performed by
MRNI’s qualified service personnel at MRNI’s facility.
The life expectancy of these products is based on PERIODIC INSPECTION and
REPAIR performed by MRNI.
These products can last indefinitely when they are inspected and repaired as needed
and at the recommended frequency.
MRNI recommends the following:
Product Service Frequency
Mick 200-TP Applicator Every 50 Implants
Mick 200-TPV Applicator Every 50 Implants
Mick Reusable Magazines Every 50 Implants
IMPORTANT: WHEN A MALFUNCTION OCCURS, IMMEDIATELY CONTACT
MRNI TO OBTAIN A RETURN AUTHORIZATION NUMBER AND
INSTRUCTIONS TO SEND PRODUCT IN FOR REPAIR!
7
Mick Magazines
Various Types, Sterilization Procedures, Radiation Safety, Waste Disposal
♦ Mick Magazines can be “AUTOCLAVED”. (Autoclave disposable magazines only once!)
♦ Seed manufacturers may provide Mick Magazines pre-loaded, packaged and shipped
sterile.
♦ Mick Magazines are compatible with the Mick 200-TP Applicator.
♦ Disposable Mick Magazines are for “ONE-TIME” Use Only!
AVAILABLE TYPE MICK MAGAZINES
CAPACITY
TYPE CAT. # MATERIAL STERILIZATION
(# OF SEEDS)
A) REUSABLE 20 20
SHIELDED 0410 ST. STEEL AUTOCLAVE
B) REUSABALE 10 10
SHIELDED 7609 ST.STEEL AUTOCLAVE
C) DISPOSABLE 15 15 PES
UNSHIELDED 7609-D (POLYETHERSULFONE) AUTOCLAVE
D) DISPOSABLE 15
0216-DS 15 PES,
AUTOCLAVE
SHIELDED PLATED BRASS
STERILIZATION PROCEDURES
STERILIZATION: AUTOCLAVE:
Temperature: 250°F / 121°C
Pressure: 15 psig
Sterilization Time: 30 Minutes
STERILIZATION: FLASH CYCLE:
Temperature: 270° F / 132°C
Pressure: 27 psig
Sterilization Time: 10 Minutes
A B C D
RADIATION SAFETY / WASTE DISPOSAL
♦ Check for residual seeds in all areas around the surgical site.
♦ Store residual seeds in appropriately shielded containers.
♦ Conduct a radiation survey on the Mick Applicator.
♦ Conduct a radiation survey on all used needles.
♦ Conduct a radiation survey on all used disposable magazines (cartridges).
♦ Conduct a radiation survey on accessory tables.
♦ Conduct a radiation survey on drapes and disposable items prior to disposal!
♦ Document number of seeds implanted.
♦ Document number of seeds unused.
♦ DO NOT EXIT THE OPERATING SUITE WITHOUT A THOROUGH RADIATION SURVEY
EXECUTED BY A RADIATION SAFETY OFFICER.
♦ FOLLOW HOSPITAL RULES AND PROCEDURES FOR THE DISPOSAL OF SHARPS AND
OTHER USED HAZARDOUS MATERIALS.
8
Sterilization Procedure
Validated
Recommended Sterilization Procedures for
MICK 200-TP Applicator and Accessories
ITEMS THAT CAN BE AUTOCLAVED OR GAS (EtO) STERILIZED:
The Mick 200-TP Applicator and Accessories such as Reusable and Disposable Magazines,
Loading V-Block, Reverse Action Tweezer, Stainless Steel Ruler, Loop Wire, Allen wrench,
Seed Sterilizer and Insert, Reusable Transperineal Templates, Diddler and Sterilization Cassette
CAN BE AUTOCLAVED or GAS (ETO) STERILIZED.
ITEMS THAT CANNOT BE AUTOCLAVED OR GAS (EtO) STERILIZED:
All plastic and packaging material must be removed prior to steam sterilization.
Practice Phantoms and Sterile / Disposable Mick TP Needles CANNOT be sterilized.
*VALIDATED STERILIZATION PARAMETERS
Remove Pushwire Rod Assembly from Applicator for Cleaning
and Sterilization and place these and other Accessories being
sterilized into the Sterilization Cassette or Tray.
A) AUTOCLAVE: Gravity Displacement or Pre-vacuum
TEMPERATURE: 250º F / 121° C PRESSURE: 15 psig
STERILIZATION TIME: 30 MINUTES (In Stainless Steel Tray)
45 MINUTES (In Sterilization Cassette)
B) FLASH CYCLE: Gravity Displacement or Pre-vacuum
TEMPERATURE: 270º F / 132º C PRESSURE: 27 psig
STERILIZATION TIME: 3 MINUTES (In Sterilization Cassette or Stainless
Steel Tray - MICK 200-TP APPLICATOR ONLY)
C) GAS (ETO) STERILIZATION:
TEMPERATURE: 135º F / 57º C PRESSURE: 8.5 psig
STERILIZATION TIME: 1 HOUR & 45 MINUTES
AERATION TIME: 12 HOURS
* The use of sterilization protocols other than the above
are the responsibility of the user.
9
Cleaning Procedures
Recommended
Recommended Cleaning Procedures
Mick 200-TP Applicator & Accessories
Catalog # 8810
Ultrasonic Cleaners:
For Best Cleaning Results Use Ultrasonic Cleaning Devices
ULTRASONIC CLEANING REACHES INTO SMALL AND INACCESSIBLE CREVICES THROUGH
HIGH FREQUENCY VIBRATIONS TO LOOSEN RESIDUAL BLOOD AND TISSUE. CONTINUOUS
RINSING DURING SURGERY AND IMMEDIATELY THEREAFTER, WILL PREVENT BLOOD
FROM CLOTTING WITHIN THE APPLICATOR.
Recommended Ultrasonic Cleaner
Catalog # 7908-7 / Capacity: 2.5 Gallons
Tank Size: 19.5” x 5.25” x 6” (LWH)
The Mick 200-TP Applicator with its many “moveable parts” (see pages 3 and 4) requires
thorough cleansing as blood frequently finds its way through the needle and into the needle
receptor. The needle receptor containing the spring-loaded finger, which latches onto the
needle, must remain free of blood or tissue. If left without maintenance, the needle may not
hold properly (See page 5).
Prior to and most importantly during the surgical procedure, it is highly
recommended to continuously rinse the applicator and its moving parts in sterile
water.
Recommended Cleaning and Disinfectant Agents
Ecolab: Asepti-Solid System (www-st.ecolab.com)
Steris (www.steris.com)
Or, use those recommended by the hospital.
NOTE: COMMONLY USED SURGICAL INSTRUMENT CLEANERS AND
DETERGENTS ARE NOT DESTRUCTIVE AND DO NOT AFFECT OR COMPROMISE
THE INTEGRITY OF THE APPLICATOR.
10
Mick TP “Ripple-Hub” Needle
Needle Specifications
Sterile • Disposable • Siliconized • Calibrated • Economical
Cat. # MTP-1820-C Cat. # MTP-1720-C
18 Gauge 17 Gauge
Brachytherapy Mick TP “Ripple-Hub” Needle
Catalog # Description Hub Color Quantity
MTP 1720-C 17 Gauge x 20cm Blue Hub 25 needles per box: 3 packs of 5 needles
and 10 single needle packs.
MTP 1820-C 18 Gauge x 20cm Yellow Hub 25 needles per box: 3 packs of 5 needles
and 10 single needle packs.
The Mick TP “Ripple-Hub” Needles are designed and
manufactured in accordance to Mick tolerances and
specifications. Emphasis and special attention are given to
the needle’s compatibility with Mick 200-TP and 200-TPV
Applicators. The fit of the needle within the applicator’s
needle receptor is carefully controlled. More importantly, the
entrance hole to the needle is funneled for smooth transfer
of seeds from magazines into the needles. The calibration
allows setting needles to equal depths (if so desired) without
the necessity of rulers. The bands are 5mm long with 5mm
clear areas in between.
INSTRUCTION FOR USE:
To insert the needle, it is imperative to apply pressure to the needle hub DISCLAIMER:
only.
STERILITY: Mick Radio-Nuclear
“AUTHENTIC” Mick TP Needles are packaged sterile in cartons of 25 Instruments, Inc.
needles each. Each carton contains 3 pouches @ 5 needles each and voids all liabilities and
10 pouches @ 1 needle each.
warranties when Mick 200-
WASTE DISPOSAL: TP and Mick 200-TPV
Dispose of used needles in accordance with hospital “hazardous waste”
Applicators are used with
management procedures.
Disposable Needles, Seed
CAUTION: Magazines or Products other
Do not AUTOCLAVE the Mick Applicator with a disposable needle than those manufactured or
inserted . The needle’s plastic hub will melt inside the needle chuck authorized by MRNI, Inc.
which will render your instrument defective and unusable.
11
Mick TP “Ripple-Hub” Needle
Detailed Illustration
Ripple-Hub
with Orientation Groove
Needle Sleeve - Funneled
10mm Echogenic
Canula Tip
Trocar Point
Description:
The Mick TP Ripple-Hub Needle is available in both 17 and 18 gauge. The stainless steel obturator fits snugly
into the needle cannula to add rigidity to the needle. When inserted correctly, the needle hub rests against the
needle sleeve and the trocar point tip protrudes from the cannula. When inserted incorrectly, the trocar point
tip of the obturator will slide back into the cannula and remains invisible. (SEE PROPER HANDLING BELOW)
NEEDLE INSERTION
IMPLANT THE NEEDLE WITH PRESSURE
TO THE HUB, NOT TO THE SLEEVE OR SHEATH!
NEEDLE DISPOSAL (SHARPS)
Take care to prevent injuries when using needles, scalpels, and other sharp instruments or devices; when
handling sharp instruments or devices; when handling sharp instruments after procedures; when cleaning
used instruments; and when disposing of used needles. Never recap used needles or otherwise manipulate
them using both hands, or use any other technique that involves directing the point of the needle toward any
part of the body; rather, use either a one-handed “scoop” technique or a mechanical device designed for
holding the needle sheath. Do not remove used needles from disposable syringes by hand and do not bend,
break or otherwise manipulate used needles by hand. Place used disposable syringes and needles, scalpel
blades, and other sharp items in appropriate puncture-resistant containers, which are located as close as
practical to the area in which the items are used, and place reusable syringes and needles in a puncture-
resistance container for transport to the reprocessing area.
MATERIALS USED:
Mick TP Ripple-Hub Needles are made of the finest quality stainless steel where as the hubs and the sleeves
are made of plastic materials. DO NOT AUTOCLAVE DISPOSABLE NEEDLES!
12
Morgenstern-Prostate Stabilization Needle
Distributed By:
Mick Radio-Nuclear Instruments, Inc.
521 Homestead Avenue
Mount Vernon, NY 10550
Tel: 914-667-3999
Prostate Stabilizing Needles Can be Autoclaved!
Fax: 914-665-98834
E-mail: sales@micknuclear.com
13
Precautions
Radiation Safety
Radiation Protection
Radiation Safety:
Personal Radiation Monitoring:
The use of the Mick Applicators and accessories entails solid radioactive nuclides such as I-125, Pd-103
or Au-198. As with any radioactive materials, the principles of RADIATION PROTECTION; TIME,
DISTANCE and SHIELDING should be followed. Radioactive materials should not be handled without the
necessary personal monitoring devices such as DIRECT READING POCKET DOSIMETERS, FILM and
RING BADGES. Do not underestimate the radiation exposure from low-energy radionuclides. Treat
radiation with respect and follow the ALARA principle; keep the exposure:
“AS LOW AS REASONABLY ACHIEVABLE”!
Never touch or pick-up radioactive seeds with your fingers; use reverse action tweezers provided by
MRNI.
To check for residual seeds in needles or areas close to the implant, RADIATION SURVEY METERS are
required. (Devices as listed above are available through this company - see bottom of this page)
Radiation Protection:
Radioactive materials should not be handled without proper SHIELDING. The loading of seeds into
cartridges should be done behind a protective (Pb) L-SHIELD. Wearing lead-lined rubber gloves
significantly reduces exposure to fingers and hands. When implanting I-125 seeds, it is recommended that
a THYROID SHIELD is worn. Implants done under FLUOROSCOPY, require the use of LEAD APRONS.
INDIVIDUALS UNFAMILIAR WITH RADIATION SAFETY PROCEDURES AND PERTINENT
REGULATIONS SHOULD CONSULT WITH RADIATION SAFETY PERSONNEL PRIOR TO
UNDERTAKING AN IMPLANT WITH RADIOACTIVE NUCLIDES. IT IS IMPERATIVE THAT ALL
NECESSARY RADIATION PRECAUTIONS ARE IN PLACE. PERSONNEL, PATIENTS AND PATIENT’S
FAMILIES MUST BE GIVEN THE PROPER INSTRUCTIONS BY THE PHYSICIAN OR INSTITUTION
PRIOR TO PATIENT’S RELEASE .
A number of Guidelines are available through the National Council of Radiation
Protection and Measurements , (www.ncrponline.org.)
Radiation Alert The INSPECTOR is a small handheld microprocessor based
INSPECTOR instrument which offers excellent sensitivity to low levels of
The Ideal “Low-Energy” Seed Finder alpha, beta, gamma and x-rays. The digital readout is
displayed with a red count light and audible beep, providing
instant indications of the radiation level. Other benefits
include an adjustable timer and external calibration controls.
Specifications:
Detector:
Halogen-quenched
uncompensated GM tube
with thin mica window,
1.4-2.0mg/cm² area
density.
Effective diameter of window: 45mm (1.75 in.)
Smallest detectible level for I-125 is 0.02µCi at contact.
Size: 150 x 80 x 30 mm (5.9 x 3.3 x 1.2 in.)
Includes: CE certification, 1 year limited warranty, Please call Mick Radio-Nuclear Instruments, Inc.
padded vinyl carrying case with belt loop.
for more detailed information on the INSPECTOR!
14
Implant Sequence
Recommended
Seed Implant Sequence with the Mick 200-TP Applicator:
Please note:
The seed implant sequence may vary depending on the user’s preferences, previous experience and training.
Many physicians have their own ways and techniques of using the Mick Applicator. It Is highly advisable for
new users to attend training sessions or to attend “live demonstrations” and to be proctored by experienced
physicians during the first few prostate seed implants. The descriptions and recommendations as offered
herein are technical only. Clinical aspects of the procedures are the sole responsibility of the user.
Before getting started:
♦ Check for the Mick 200-TP Applicator to be in perfect operating condition prior to use.
♦ Check for the availability of seeds and back-up instrumentation for use in the OR.
♦ Check for availability of Mick “Ripple-Hub” Needles.
♦ Check for type of isotope prescribed by the physician; Pd-103 or I-125 or others.
♦ Check labeling on the Seed Sterilizer for prescribed isotope, activity and name of patient.
♦ Check for the availability of radiation survey equipment.
Recommended Implant Sequence:
1. Attach the Mick 200-TP Applicator to the implanted Mick Ripple-Hub Needle.
Hold the needle with fingers at the template while attaching the Mick Applicator. Ensure that the needle is attached
firmly. Conduct a pull test! Pull lightly on applicator while still holding the needle at the template. If not fully engaged,
the needle will slip back out of the needle receptor.
2. Advance Template Ring forward until flush with Transperineal Template.
Hold the Mick 200-TP Applicator steady while advancing the Template Ring. Do not displace the implanted needle.
3. Retract the Pushwire Rod (stylet) completely.
Pull stylet out as far as possible while holding the Mick Applicator steady against the template.
4. Insert loaded Seed Magazine into the Mick 200-TP Applicator.
Note the direction for inserting the cartridge; insert cartridge into the well of the magazine receptor—
seeds must face to the right. (See insert page 6.) Magazine is properly seated when a noticeable click is heard.
5. Retract Needle by “1” click. (1 click = 5 mm)
While steadying the applicator, retract the needle by 1 click (5mm). This creates a channel and space for the
placement of the first seed. Hold the applicator steady against the Template while retracting the needle.
6. Drop Seed # 1. Advance the Pushwire Rod (stylet) as far forward as possible.
CAUTION: PUSH THE STYLET FORWARD CAUTIOUSLY — DO NOT PUSH FURTHER THAN TO STOP;
IF PUSHED TOO HARD - THE NEEDLE WILL BE DISPLACED DISTALLY.
7. Retract the Mick Ripple Hub Needle by the desired distance using the “2 click” method.
2 clicks = 1cm. Caution: RETRACT THE NEEDLE PRIOR TO RETRACTING THE PUSHWIRE ROD (stylet).
This sequence helps to separate the seed from the needle and from migrating proximally.
8. Pull the Pushwire Rod (stylet) back out of the Mick Applicator as far as possible.
When the stylet is pulled past the magazine, a new seed automatically drops into place.
9. Drop seed # 2. Advance the Pushwire Rod as far as possible. (Repeat as above)
When retracting the stylet, watch for the magazine plunger to descend - listen to the click.
Caution: If the plunger does not drop - the magazine may be empty or has jammed. In the unlikely event
of a jam, replace magazine with a new one. DO NOT USE FORCE TO REMOVE THE MAGAZINE. Unscrew the
magazine head a couple of turns counter clock wise to release the tension on the seeds. Then try to remove the
magazine. Always keep track of the number of seeds implanted.
10. Once the number of seeds per needle are deposited, pull the applicator with the needle
out of the template. Then disconnect the needle from the applicator by pressing the needle release
button (see page 5).
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Implant Sequence - (Continued)
Recommended
Useful Tips During the Implant Procedure:
When Loading the Magazine into the Applicator, ensure the Magazine sets into the Applicator properly, loading
with a noticeable “Click”.
Ensure the needle is properly connected to the Applicator. The needle should “CLICK” into the Needle Receptor
and should not disconnect unless the Needle Release Button is depressed.
During implantation, ensure the seed is completely advanced through the needle. Do not advance the seed par-
tially out of the cartridge and retract the Push-Wire Rod. This may cause the seeds to drop unevenly and seeds
may become jammed in the cartridge.
When loading Mick Magazines, visually check that the seeds are loaded straight and parallel in the cartridge. If
the seeds are placed askew in the cartridge, it may cause jamming during the implant procedure.
After an implant procedure, it is strongly recommended a physical seed inventory be performed to account for all
seeds.
Dislodging Jammed Seeds:
If and when a seed is jammed between the Applicator Needle Chuck and the Seed Cartridge, DO NOT force the
seed Magazine out of the Magazine receptor area of the Applicator. Undue pressure on the seeds may cause
the seeds to break or rupture. The following techniques can be attempted:
♦ Partially unscrew the head of the magazine (no more than one turn), thereby relieving the downward pres-
sure on the seeds. Please note that the Magazine Head and the cartridge are NOT designed or intended to
be taken apart. This is only done to relieve the spring pressure on the seeds. Carefully attempt to remove
the Magazine from the Applicator. DO NOT USE FORCE; PREVENT SEEDS FROM RUPTURING!
♦ Flush the jammed seed out of the Applicator using a light pressure water flush. This must be done over a
collection pan situated such that all seeds are collected and accounted for.
If the seeds cannot be removed safely, place the Applicator in quarantine. The Applicator must be surveyed (for
radiation) to determine if a broken seed has contaminated the Applicator.
If contaminated, the Applicator must remain in quarantine for a minimum of 10 half-lives for I-125 or Pd-103
seeds.
If clean, it is recommended that the Applicator be returned to the manufacturer for evaluation and repair/
adjustment.
Returning an Applicator for Service or Repair:
1: Call MRNI, Inc., Customer Service Tel. 914-667-3999 to obtain a “Return Authorization” number and a
Certificate of Decontamination, Form 414-10.
2: Mick Applicators (Instrument only) must be sterilized before sending to MRNI, Inc.
3: MRNI, Inc. will fax you form #414-10 to be completed by you (without the proof of a decontamination form,
your Mick Applicator will be returned unserviced).
Upon MRNI’s Receipt of Mick Applicator:
The Mick Applicator will be analyzed to determine the extent of the repair. We will then call the Contact Person
to get authorization for repair and cost before we commence with any work.
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Useful Tips
Useful Tips
Useful Tips
Preparations
Prior to surgery it is imperative that the instrumentation is in proper operating condition
and that all components necessary are accounted for. The Mick sterilization cassette is con-
structed to store and simultaneously sterilize all components required for surgery. (Seeds
excluded.)
“DO NOT AUTOCLAVE THE PRACTICE PHANTOM & DUMMY SEEDS” (see page 9)
SEPARATE DUMMY SEEDS FROM RADIOACTIVE SEEDS!
DO NOT IMPLANT DUMMY SEEDS!
CAUTION
REMOVE PUSHWIRE ROD ASSEMBLY AND DISPOSABLE NEEDLES
FROM THE MICK APPLICATOR PRIOR TO STEAM STERILIZATION.
Disposable needles are manufactured with “plastic” sleeves and hubs.
When inserted into the needle chuck and steam sterilization takes place,
the needle sleeve will melt inside the needle receptor. Further use of the
applicator is therefore no longer possible unless factory repaired.
Seed Accountability
It is imperative to label the “radioactive” seed carriers (Seed Sterilizer) properly. Attach
an appropriate “CAUTION-RADIOACTIVE” label which clearly states the name of the pa-
tient, date, type of isotope, number of seeds and “ACTIVITY” of the seeds.
The label must be dated and signed!
Post Surgery Check
Check used needles, instrumentation, containers, drapes, floor and all other
related items for residual seeds with an appropriate and calibrated
radiation survey meter. Every seed must be accounted for.
ALL SURGICAL PRODUCTS USED DURING THE SURGERY MUST BE
ACCOUNTED FOR!
Ball-Tipped Protective Sheath
When you receive your new Mick 200-TP Applicator you will find that the tip of the attached
protective sheath (cannula) is provided with a stainless steel ball. The protective sheath is not
a needle but serves to protect the stylet from getting damaged or bent when the instrument is
not in use.
Unless in use, or undergoing sterilization in the cassette, always protect the
Mick 200-TP Applicator’s stylet by keeping the PROTECTIVE BALL-TIPPED SHEATH
attached to the applicator.
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Useful Tips Continued
Useful Tips/Things to be Aware Of!
Loading V-BLOCK: Loading of Seeds into Cartridges using the V-Block!
In order to facilitate the seed loading process, a V-Block is provided. The V-Block is designed to place the
cartridge into a fixed and stable position. The Loading V-Block can be autoclaved. Additionally, up to 5
magazines can be stored in the V-block, however, this device provides adequate shielding for I-125 and Pd-
103 seeds, but it is not designed to provide shielding for Au-198 seeds.
Isotopes: The difference between Au-198, 1-125 and Pd-103 Seeds:
Rarely used but still in practice, Gold seeds are approximately half in length as I-125 or Pd-103 seeds. Gold
seeds are “gold colored” and compatible with cartridges specifically manufactured for Au-198 seeds; they are
color coded “GOLD”. I-125 and Pd-103 are difficult to differentiate as they are the same in color, length and
diameter. Please refer to seed manufacturers information for more detailed seed specifications.
Caution: Seeds are fragile and may rupture when handled with excess force!
It is imperative to handle radio-isotopes with utmost care. Never use force, especially so during the seed
loading process. Pick up seeds gently, preferably with the Reverse-Action Tweezer as provided by Mick
Radio-Nuclear Instruments, Inc.
HANDLING MICK MAGAZINES
Do not handle loaded magazine by the extended plunger.
Loaded magazines are NOT designed to be taken apart. The internal cartridge contains radio active seeds
under spring pressure and disassembling may cause the seeds to fall out.
Reverse Action Tweezer
Reverse Action Tweezers are provided with a groove at the tip. The groove is shaped in form and size of a
seed. When picking up seeds, the groove captures the seed which facilitates the loading of the cartridge. It is
important to keep the groove looking downward. Keep the three marks located on the handle of the Reverse
Action Tweezer on top. This is to indicate that the groove is facing downward.
Loop Wire (Stainless Steel Wire provided in kit)
A thin wire with a loop at the end is enclosed with the kit. This wire serves to check needles for residual
seeds once removed from the implant. Simply push the wire through a needle to ascertain that no seed
(s) are left within the needle. It is advisable to have an empty cartridge, a tweezer, a V-Block and a
radiation monitor at hand when checking for residual seeds.
Maintenance/Service:
Repair / service of Mick Applicators (see page 7).
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Return Authorization Number
IN ORDER FOR MICK RADIO-NUCLEAR INSTRUMENTS, INC. TO RECEIVE AND ACCEPT AN
INSTRUMENT FOR CLEANING, SERVICE OR REPAIR, A
“CERTIFICATE OF DECONTAMINATION” (Form #414-10)
MUST BE FILLED OUT BY THE CUSTOMER TO RECEIVE A
“RETURN AUTHORIZATION NUMBER”.
FAILURE TO FILL OUT THE “CERTIFICATE OF DECONTAMINATION” FORM PROPERLY AND
PRIOR TO DELIVERY WILL RESULT IN THE DEVICE BEING RETURNED TO THE CUSTOMER
UNOPENED AT CUSTOMERS EXPENSE.
Returning “HOT” Applicators
DO NOT SHIP “HOT” APPLICATORS
RETURNING UNAUTHORIZED HOT OR CONTAMINATED APPLICATORS COULD RESULT IN
LOSS OF YOUR APPLICATOR IN ADDITION TO THE COST OF THE REMOVAL AND
DISPOSAL PROCESS BY ENVIRONMENTAL WASTE MANAGEMENT.
(New York State Department of Health, Radiological Health Unit)
Warranty
SIX (6) MONTHS PARTS / LABOR FOR DEFECTIVE MERCHANDISE ONLY!
THE WARRANTY DOES NOT COVER ANY INJURY, LOSS, OR DAMAGE CAUSED BY
IMPROPER USE OR HANDLING OF THE PRODUCT OR ANY USE OF THE
PRODUCT IN CONNECTION WITH ANOTHER MANUFACTURER’S
NEEDLES, MAGAZINES OR PRODUCTS.
Disclaimer
MICK RADIO-NUCLEAR INSTRUMENTS, INC. VOIDS ALL LIABILITIES AND WARRANTIES WHEN
MICK 200-TP APPLICATORS ARE USED WITH DISPOSABLE OR REUSABLE NEEDLES OR DISPOSABLE
CARTRIDGES OR COMPONENTS OTHER THAN THOSE AUTHORIZED BY
MICK RADIO-NUCLEAR INSTRUMENTS, INC.
DATA PROVIDED HEREIN IS FOR INFORMATIONAL PURPOSES ONLY AND IS NOT INTENDED
FOR CLINICAL USE OF ANY NATURE. USE OF THIS DATA IN SUCH A MANNER IS THE SOLE
RESPONSIBILITY OF THE USER, AND THE AUTHOR OR SUPPLIER OF THE INFORMATION MAKES
NO CLAIM OR INFERENCE AS TO ITS CLINICAL SUITABILITY AND /0R ACCURACY. THE AUTHOR AND
OR DISTRIBUTOR OF THIS DOCUMENT ACCEPT NO RESPONSIBILITY FOR THE USE OF THE DATA
AND INFORMATION CONTAINED HEREIN. MICK RADIO-NUCLEAR INSTRUMENTS, INC. ASSUMES NO
WARRANTY OR LIABILITY FOR USE OF THIS INFORMATION OR PRODUCT.
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